Depression Tie to Help Lundbeck Pill to Curb Drink Binges

Dec. 17 (Bloomberg) -- Depression and alcoholism sometimes
go hand in hand. H. Lundbeck A/S is counting on that connection
to help it sell a new anti-binge-drinking pill.

At least 15 percent of those suffering from major
depression are also alcohol dependent, according to academic
research. Lundbeck thus plans to market the medicine to
psychiatrists who treat patients suffering from both conditions,
said Andreas Eggert, the executive in charge of commercializing
the pill, called Selincro. Lundbeck, which last week won backing
for Selincro from the European Union drug regulator, will draw
on its expertise selling psychiatric treatments such as the
anti-depressant Lexapro.

“There are a lot of similarities in the treatment of
depression and the treatment of alcohol dependency,” Eggert
said in a telephone interview. “We see a significant overlap
with our existing sales force structure.”

Selincro, if approved, would be the first drug designed to
treat alcohol abuse while allowing patients to continue
drinking. Besides the EU, the company also plans to seek
approval next year in Russia, where every fifth death results
from alcohol abuse. Success for Selincro may shift the treatment
of alcohol dependency away from abstinence, said David Nutt, a
professor of neuropsychopharmacology at Imperial College London.

Lundbeck, based in Copenhagen, also will target general
practitioners and alcohol-treatment centers. The European
Medicines Agency recommended Dec. 14 that the European
Commission grant Lundbeck approval to market the drug. The
commission usually follows the agency’s recommendations.

Gaining Reimbursement

While sales may reach 400 million kroner ($70 million) in
2016, success will depend on Lundbeck’s ability to work with
governments in gaining reimbursement and publicly funded
awareness campaigns, said Tim Race, a London-based analyst at
Deutsche Bank, in a note to investors on Dec. 14.

Selincro, licensed from Turku, Finland-based Biotie
Therapies Oyj, is designed to curb a person’s urge to have more
than a few drinks in one sitting by blocking brain signals that
make activities like drinking feel good.

In studies, patients were instructed to take one tablet one
or two hours before the anticipated time of drinking. In one
late-stage trial, monthly total alcohol consumption fell from 75
grams per day on average to 16 grams per day after one year of
treatment, Lundbeck said. Mild side effects, such as insomnia
and nausea, decreased over the course of treatment.

Abstinence Alternative

The pill, whose chemical name is nalmefene, offers an
alternative to those who are unable to abstain from alcohol,
which is the approach advocated by most experts, or are
unwilling to try. More than two-thirds of patients who enrolled
in the clinical trials for Selincro had never received
treatment, the company has said.

“Many of these patients are already in the physician’s
office” for depression, Eggert said. “But the dialogue is not
happening because the only option available is abstinence.”

Because Lundbeck hasn’t conducted any trials studying the
interaction between antidepressants and Selincro, it can’t
recommend any combination treatment, he said. Instead,
physicians may opt to take a sequential approach, which will
require them to decide which condition to treat first.

Previous studies of patients taking antidepressants with
approved drugs to treat alcohol dependence suggest the
combination isn’t harmful, and may even be beneficial, said
Imperial College London’s Nutt.

Combination Therapy

A University of Pennsylvania study published in the
American Journal of Psychiatry in 2010 showed that Pfizer Inc.’s
Zoloft antidepressant combined with naltrexone, a generic drug,
produced a 54 percent rate of alcohol abstention, compared with
21 percent and 28 percent, respectively, for the drugs taken on
their own. The combination also produced fewer side effects than
the single treatments.

Naltrexone differs from Selincro in that it is approved as
a treatment to maintain abstinence, not to control consumption
without quitting.

“I’d be very surprised if there were negative
interactions” between Selincro and anti-depressants, said Nutt,
former president of the British Association of
Psychopharmacology. “It makes perfect sense to use an
antidepressant workforce to market this drug; they’re both
psychiatric diseases.” He has received grants or fees for
consulting or speaking from drugmakers including Lundbeck,
though he didn’t play a role in any research on Selincro.

European Drinking

Annual per capita alcohol consumption in Europe, at 12.18
liters (3.2 gallons), is double the global average and 40
percent higher than in the Americas, according to World Health
Organization statistics.

Selincro hasn’t yet been filed in the U.S., where it would
be protected from generic competition for only five years,
compared with 10 years in Europe, according to the company. U.S.
regulators also may have a preference for drugs that aid with
abstinence over one that curbs binge drinking, said James
Garbutt, medical director of the Alcohol and Substance Abuse
Program at University of North Carolina at Chapel Hill.

While Alkermes Plc’s long-acting injectable version of
naltrexone was studied to reduce heavy drinking, in the end, the
Food and Drug Administration approved it only for abstinence
maintenance, said Garbutt, lead author of the study published in
2005.

“That sends the message that they were hesitant to approve
a drug based on reduction of heavy drinking,” said Garbutt, who
no longer consults for Alkermes and doesn’t consult for
Lundbeck.

Unlike with naltrexone, patients would take Selincro as
needed, instead of on a steady regimen.

Patient Decision

“We like the concept that the patient is in charge,”
Lundbeck Chief Executive Officer Ulf Wiinberg said in an
interview this month.

Once the drug has been introduced in Europe and doctors and
patients gain experience using it, Lundbeck may open up
discussions with regulators in other countries such as the U.S.,
Japan, South Korea, and China, Wiinberg said.

“Our focus is now on Europe and getting Europe fixed
first,” he said.

Alcohol abuse results in 2.5 million deaths each year, more
than those caused by AIDS or tuberculosis, according to the
Geneva-based WHO. Globally, the highest proportion of alcohol-related mortality is in Russia and neighboring countries.

Lundbeck plans to submit Selincro to Russian regulators in
the first half of 2013, Eggert said. Russia is aiming to almost
halve per capita annual consumption of alcohol to 8 liters by
2020, the level accepted by the WHO.

Unmet Need

While there is a significant unmet need for a drug like
Selincro in Russia, sales may depend on the price because many
medicines in the country have a large out-of-pocket component
that consumers have to pay, said Michael Kleinrock, director of
research development at the IMS Institute in Plymouth Meeting,
Pennsylvania.

“If the payer doesn’t carry a large amount of the cost,
then it’s down to whether the patient can afford it,” Kleinrock
said.

Other alcoholism therapies include the generic drug
disulfiram and Forest Laboratories Inc.’s Campral, used to help
patients who have abstained. Disulfiram causes illness when
alcohol is consumed, while Campral eases symptoms of withdrawal
such as anxiety and insomnia.

Success of Selincro may vary by country, as doctors in some
still don’t believe in medical treatment for addictions, though
they are becoming a minority, Nutt said. The U.K. and Sweden
prefer abstinence, while France, Italy and Germany are more
interested in drug treatments, he said.

Drugs aren’t always the best or only form of treatment for
mental disorders, which can include behavioral therapy, said
Seena Fazel, senior lecturer at the University of Oxford’s
department of psychiatry.